Primecuts – This Week In The Journals

March 19, 2014

By Anjali Mone, MD

Peer Reviewed

While the majority of media coverage is focusing on Crimea’s annexation and continued upheaval in the Middle East, also making the news this week was a high school teacher who lost weight while on an unconventional diet. John Cisna, a science teacher from Iowa, managed to lose 56 pounds and more shockingly saw an improvement in his cholesterol profile after eating only at McDonald’s for 6 months. [1] How could a diet of Quarter Pounders, salty fries, Chicken McNuggets, and McFlurries have led to improved health? There is no secret to Cisna’s success because at the end of the day, it’s simple mathematics; more calories expended than calories consumed equals weight loss. But this leads to another question; even if he lost weight, did he do it the “wrong” way? Does a diet so high in “bad fat” mean he’s at an increased risk for heart disease?

While Cisna was dieting at McDonald’s, researchers were investigating whether saturated fats are really to blame for heart disease. Their study, a large meta-analysis published in the Annals of Internal Medicine, collected data from 72 separate studies that included more than 650,000 people from 18 different countries. Their primary endpoint was to look at the association between fatty acids and coronary disease. To investigate their endpoint they looked for a relationship of three different measures with coronary disease: dietary fatty acid intake, biomarkers for circulating fatty acids, and fatty acid supplementation.

This study challenges the way we currently look at dietary fats. In fact the amount and specific type of fat (saturated or unsaturated) may not have as much to do with heart disease as we once thought. [2] This data contradicts the previously held theory that heart healthy diets are ones rich in polyunsaturated fats and low in saturated ones. Though this study and Cisna’s experiment could be misinterpreted as a green light to eat anything you like, the fact remains that diets with excessive amounts of fat are still more likely to lead to weight gain and ultimately heart disease. The take home point from these trials is that moderation is the key to a healthy diet.

Along with the theme of prevention and treatment of heart disease, the Lancet published an article this week looking at coronary stents and cardiac outcomes, challenging the traditional 1-yr primary endpoint to assess for major adverse cardiac events (MACE) after patients are treated with coronary drug eluting stents. Though there is still no established optimal timeline to assess for adverse outcomes after coronary stenting, data from a recent study suggests that 1-yr findings may not be sufficient to predict of long term outcomes. In the SORT OUT III trial, which this a comparison of 5-yr and 1-yr outcomes were made for patients that received two different types of drug-eluting stents.

The SORT OUT III study was initially a randomized controlled superiority trial comparing the safety and efficacy of zotarolimus-eluting and sirolimus-eluting coronary stents. In the original trial 1162 patients were randomized to receive zotarolimus stents and 1170 to sirolimus stents. Researchers looked at outcomes at 9 and 18 months and the results were notable for an increase in all cause mortality in patients who received zotarolimus stents compared to sirolimus stents [4% vs 3%; p=0.035] and an increase in MACE in patients with zotarolimus stents [8% vs 3.9%, OR 2-13, 95% CI 1.48-3.07; p<0.0001). [3] Surprisingly, however, the comparison of these end points is markedly different in a more recent publication from the study’s 5 year outcomes.

In fact, at 5 years the same study showed no significant difference in MACE between the two types of stents [197/1162 (17%) zotarolimus vs 182/1170 (15.6%) sirolimus, OR 1.10, 95% CI 0.88-1.37; p=0.4]. Furthermore, when looking at stent thrombosis, comparatively worse outcomes were noted for the sirolimus-eluting stents after 5 years, even though it appeared to be superior at the 1 year time mark. These new data challenge the traditional use of a 1-yr endpoint for assessment of MACE after coronary drug-eluting stents and suggest such a short follow-up period may not be useful in predicting long-term outcomes. [4]

Also publishing about heart disease prevention and treatment, a Canadian journal published an article about gender disparities in treating patients with chest pain. Given that acute coronary syndrome (ACS) rates are higher among men than women and that women are more likely to present with atypical symptoms for chest pain, it is not surprising that a recent study published in the Canadian Medical Association Journal (CMAJ) found that there are gender differences in ACS triage and treatment. Men, and very interestingly all individuals with masculine traits, are more likely to receive timely care and more invasive interventions. [5]

In this trial, 1123 patients ages 18-55 admitted to hospitals for ACS were recruited from 24 centers throughout Canada, 1 in the US, and 1 in Switzerland as part of GENESIS-PRAXY cohort study. Primary endpoints of the study focused on sex differences in time to procedure as well as sex differences in invasive procedures. The measures used to quantify these differences included door to EKG time, door to needle time (time to fibrinolytic administration), and door to balloon time, as well as cardiac catheterization, and reperfusion techniques.

Of the study population 362 (32%) were women and 761 (68%) were men, both groups of similar age. There was no significant difference in the amount of time to presenting to emergency room after the onset of chest pain between the two sexes with 4 hours and 3.5 hours for women and men respectively.

Men were more likely to receive EKGs and fibrinolytics more quickly than women based on measured door to EKG time [15 min (men) and 21 min (women); p<0.001] and door to needle time [28 min (men) and 36 min (women); p=0.02]. There was no significant difference in the time to primary percutaneous intervention (PCI) [93 min (men) and 106 min (women); p=0.7], however, women were less likely to have invasive procedures done than men for NSTEMI and unstable angina with rates of PCI at 48% in women and 66% in men (p<0.001).

The authors hypothesize that an increased incidence of concomitant anxiety and absence of a typical chest pain syndrome at presentation may contribute to the differences between the gender groups in this study. [5] This study clearly demonstrates that there is a disparity in the effectiveness of care delivery for men and women in the assessment of acute coronary syndrome, and practitioners should be further educated to help resolve this inequality.

Staying within the realm of emergency medicine, the Academic Emergency Medicine Journal published a paper on the dilemma of adequately treating patients for their pain. In the midst of a prescription opiate abuse epidemic, concerns about the over prescription of opioids are escalating. According to the Centers for Disease Control and Prevention, deaths related to prescription opioids have increased by nearly four-fold from 4030 in 1999 to 16,651 in 2010. Many are concerned about the recently FDA approved medication zohydro scheduled to hit the drug market this spring. Zohydro is pharmacologically five times more potent than current opiates and raise concerns for amplified abuse potential. [6] These concerns are validated by this recent study investigating opiate prescription trends in United States emergency rooms, which indicates there has been a significant increase over the past decade out of proportion to the moderate increase in pain-related visits.

Between 2001 and 2010 opioid prescriptions during ED visits increased from a frequency of 20.8% to 31% (95% CI=7 -13.4) while the percentage of visits for ‘painful conditions’ increased by only 4% [47.1% in 2001 to 51.1% in 2010; CI =2.3 – 5.8%].

The absolute increase in DEA schedule II drugs prescriptions was 6.9% during this period of time [95% CI =5.2 – 8.5], out of proportion to the increase in prescriptions for DEA schedules III and V, which was only 3.0% [95% CI = 2.0% to 5.7%]. Of note, the greatest increases were identified in the utilization of hydromorphone [0.9% in 2001 to 6.8% in 2010; CI=4.9-6.8] and morphine [1.6% in 2001 to 6.7 in 2010; CI=4.1 -6.1], while no significant changes were observed in non-opioid painkillers such as acetaminophen and NSAIDs. [7]

Experts attribute this upward trend to reimbursement strategies that now include patient satisfaction as part of the algorithm. Patients for whom pain is not adequately treated may report such in satisfaction surveys, subsequently leading to decreased hospital reimbursement. This is certainly an interesting phenomenon to monitor, especially with potential conflict of opiate misuse and overuse, and new standards for hospital payment.

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